The DHA (Docosahexaenoic Acid) Oxford Learning and Behaviour (DOLAB) Study

University of Oxford360 enrolled

Overview

The purpose of this study is to determine whether DHA (in a daily dose of 600 mg.) will improve the behaviour and learning of normal children aged 7-9 years in mainstream state schools who are underperforming according to nationally standardized tests.

The study has two stages, as its primary aim is to find out whether there is a real link between children's fatty acid status and their reading and behaviour. Previous reviews have stated the importance of objective measures, as did our referees. We will aim to address this by using well validated tests of reading and behaviour, and comparing results from these with children's fatty acid status as assessed from a pinprick blood sample. In Stage 1 we will primarily aim to establish the degree of association between fatty acid status and reading and behaviour. Secondarily, we will look at whether the children who have a higher DHA status have better sleep, and whether in turn they have better reading and/or behaviour, as previous work has suggested this. In Stage 2 we aim to carry out a randomised trial where children will be given either DHA or a taste- and appearance-matched dummy capsule for 16 weeks. Neither the children, parents nor the researchers will know which children will get which treatment until the study is over.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

360

Conditions

Learning Behaviour

Interventions

DHA (docosahexaenoic acid)DIETARY_SUPPLEMENT

3 x 500 mg capsules per day orally, each capsule providing 200 mg of DHA as a triglyceride. The liquid fill contains DHASCO®-S oil, derived from the microalgae, Schizochytrium sp., high-oleic sunflower oil, natural mixed tocopherols, ascorbyl palmitate, and rosemary extract (flavouring). The gelatin shell contains glycerin, water, and colouring (carmel, carmine, turmeric).

Sunflower oil capsulesDIETARY_SUPPLEMENT

The placebo will consist of 3 x 500 mg capsules per day orally containing high-oleic sunflower oil. The dimensions, taste, appearance and colour will be identical to those of the DHA capsules. The shell of the capsule will be the same as the DHA capsule. The liquid fill contains high-oleic sunflower oil, natural mixed tocopherols, ascorbyl palmitat and rosemary extract (flavouring).

Eligibility

Sex: ALLMin age: 7 YearsMax age: 10 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Children aged 7 - 9 years from mainstream state schools who are underperforming in literacy skills according to nationally standardized assessments of scholastic achievement at age 7 years (Key Stage 1 ). To be eligible, children must score below the 33rd centile for reading/writing, but within the normal range in at least one other domain. 2. English as a first language. Exclusion Criteria: 1. Major learning disabilities or medical disorders 2. Taking medications expected to affect behaviour and learning 3. Taking fish oils already, or eating fish 2 times or more a week

Locations (1)

Department of Social Policy and Social Work

Oxford, Oxfordshire, United Kingdom

Outcomes

Primary Outcomes

Conners Teacher Rating Scale (CTRS-L)

Time frame: 16 weeks

Conners Parent Rating Scale (CPRS-L)

Time frame: 16 weeks

British Ability Scale (BAS) II Word and Digit Span Scales

Time frame: 16 weeks

Secondary Outcomes

Pinprick blood levels of DHA

Time frame: 16 weeks

Child Sleep Habits Questionnaire (CSHQ)

Time frame: 16 weeks

Objective sleep as measured by actigraphy

Time frame: 16 weeks

Data from ClinicalTrials.gov

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